Metabolic Responses to InactivityBIERNCT02981927
Bed Rest, Inactivity and Early Responses
A study testing Physical inactivity in people with Metabolic Responses to Inactivity, run by University of Exeter at 1 site in United Kingdom.
Trial summary
To evaluate the early metabolic responses (whole body and within muscle tissue) to a single day of whole body physical inactivity (i.e. bed-rest), and evaluate the contribution of inactivity per se vs alterations in diet Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Responses to Inactivity
- What is being tested?
- Physical inactivity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to 2 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy and aged 18-40 y
- BMI between 18 and 30
Who cannot join
- On medication
- Family history of metabolic disease
- Diagnosed with any metabolic or cardiovascular conditions
- BMI < 18 or > 30
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the early metabolic responses (whole body and within muscle tissue) to a single day of whole body physical inactivity (i.e. bed-rest), and evaluate the contribution of inactivity per se vs alterations in diet
- Conditions
- Metabolic Responses to Inactivity
- Being tested
- Physical inactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical inactivityOther
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 24 h habitual physical activity fed in energy balance |
| Bed rest matched diet | Experimental | 24 hour period of whole body bed-rest with a matched diet Receives: Other: Physical inactivity |
| Bed rest balanced diet | Experimental | 24 hour period of whole body bed-rest fed in energy balance Receives: Other: Physical inactivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startJan 2015
- Primary completion2 Dec 2016
- Study completion2 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Responses to InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981927
- Sponsor's protocol ID
- 157758/02
- Acronym
- BIER
- Status last verified
- May 2018
- First submitted
- 30 Nov 2016
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bed Rest, Inactivity and Early Responses
- ClinicalTrials.gov ID
- NCT02981927
- Acronym / sponsor ID
- BIER / 157758/02
- Conditions
- Metabolic Responses to Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 2 Dec 2016 (actual)
- Study completion
- 2 Dec 2016 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the early metabolic responses (whole body and within muscle tissue) to a single day of whole body physical inactivity (i.e. bed-rest), and evaluate the contribution of inactivity per se vs alterations in diet
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –24 h habitual physical activity fed in energy balance |
| Bed rest matched diet | Experimental | Other: Physical inactivity24 hour period of whole body bed-rest with a matched diet |
| Bed rest balanced diet | Experimental | Other: Physical inactivity24 hour period of whole body bed-rest fed in energy balance |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy and aged 18-40 y
- BMI between 18 and 30
Key exclusion criteria (4 listed)
- On medication
- Family history of metabolic disease
- Diagnosed with any metabolic or cardiovascular conditions
- BMI < 18 or > 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical inactivity | Other | Bed rest balanced diet, Bed rest matched diet |
Primary outcome
Glucose tolerance
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical inactivity in people with Metabolic Responses to Inactivity, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose tolerance (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2018.